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MES Lead

  1. East
Leiden
  1. Contract
Competitive
  1. CAPEX Projects
30031

This vacancy has now expired

MES Lead – Pharmaceuticals – Contract – Leiden

Are you local to the Netherlands and would you like to join a leading biopharmaceutical company in their mission to make a difference, changing lives through their scientific pursuits? Our client, a discoverer and developer of innovative medicines, are recruiting for an MES Lead to join their brand-new build cell therapy project on a contractual basis.

MES Lead Responsibilities:
  • Plan and execute the Manufacturing Execution System (MES) project
  • Define and lead the Project governance and communication approach
  • Develop and manage MS project schedule, RAID logs to track, monitor and manage the project, cross-project dependencies, risks, issues, decisions, and status reporting
  • Initiate and support the delivery of a validation strategy for the site, focused on the ME MBR / recipes
  • Organise and lead meetings with key stakeholders from business and IT, Core team members, technical meetings with SMEs and external vendors (Emerson).
  • Define and align detailed requirements and estimates for the site MES.
  • Establish communication plans and meeting plans for key decisions and topics.
  • Escalation plan to leadership for important decisions and issues.
About you:
  • 5+ year’s relevant (Pharma) industry experience.
  • Prior Cell Therapy experience is highly desired.
  • Demonstrated expertise in MES technologies (Syncade) with knowledge of historian and reporting technologies.
  • Working knowledge of SDLC, GAMP, CSV and 21 CFR Part 11 regulations.
  • System integration knowledge/experience between Syncade and control systems (DeltaV) and other enterprise systems, like SAP, OSI-PI, LIMS, Maximo etc.
  • Experience with the implementation of MES, DeltaV, OSI-Pi and Building Automation
  • Systems including validation activities necessary to deliver these systems
  • Fluency in English language is required, Dutch would be a plus.
Are you a good fit for this MES Lead position? Get in touch with us today to apply.

The candidate must have the rights to work in the location stated in the job advert.

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